I 

114TH CONGRESS 

1ST SESSION H. R. 4292 

To provide for research and the testing of innovative health care delivery 

models to improve medication adherence, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 18, 2015 

Mrs. NOEM (for herself and Mr. PASCRELL) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To provide for research and the testing of innovative health 

care delivery models to improve medication adherence, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Synchronization & 

5 Nonadherence Correction (SYNC) Act of 2015’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 

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1 (1) Between one-half and two-thirds of patients 

2 with chronic diseases in the United States do not 

3 take medications as prescribed. 

4 (2) Low rates of medication adherence result in 

5 higher health care costs, reduced effectiveness of 

6 health care treatments and regimens, negative health 

7 effects for patients, and tens of thousands of deaths 

8 on an annual basis. 

9 (3) Medication adherence may be lowest among 

10 patients with chronic diseases. 

11 (4) Improving medication adherence would re12 duce unnecessary hospital admissions and emergency 

13 room visits. 

14 (5) Nonadherence is estimated to cost the 

15 United States health care system over 

16 $100,000,000,000 each year. 

17 (6) Improving medication adherence could im18 prove patient health outcomes, reduce health care 

19 costs, and lead to productivity gains. 

20 SEC. 3. DEFINITIONS. 

21 In this Act: 

22 (1) The term ‘‘applicable individual’’ means an 

23 applicable individual (as defined in section 

24 1115A(a)(4)(A) of the Social Security Act, 42 

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1 U.S.C. 1315(a)(4)(A)) who has been prescribed 2 or 

2 more chronic care medications. 

3 (2) The term ‘‘medication adherence’’ means a 

4 patient taking medications according to the pre5 scribed dosage, time, frequency, and direction. 

6 (3) The term ‘‘medication wastage’’ means, 

7 with respect to a medication, a switch of the medica8 tion or strength of the medication within the same 

9 therapeutic class that occurs before the expected re10 fill date. 

11 (4) The term ‘‘persistence’’ means the act of 

12 continuing treatment with a medication for the pre13 scribed duration. 

14 (5) The term ‘‘primary nonadherence’’ means 

15 the failure to pickup a newly prescribed medication 

16 from a pharmacy. 

17 (6) The term ‘‘Secretary’’ means the Secretary 

18 of Health and Human Services. 

19 (7) The term ‘‘synchronization’’ means the co20 ordination of medication refills for a patient taking 

21 two or more chronic medications such that the pa22 tient’s medications are refilled on the same schedule 

23 for a given time period. 

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1 SEC. 4. NATIONAL RESEARCH AND REPORTING STRATEGY 

2 FOR IMPROVED MEDICATION ADHERENCE. 

3 (a) IN GENERAL.—The Secretary of Health and 

4 Human Services, acting through the Agency for 

5 Healthcare Research and Quality, the Centers for Medi6 care & Medicaid Services, the Health Resources and Serv7 ices Administration, the Director of the National Insti8 tutes of Health, and the Director of the Centers for Dis9 ease Control and Prevention, and in coordination with the 

10 Patient-Centered Outcomes Research Institute, shall con11 duct research and develop information to better inform de12 cisionmakers regarding medication adherence and medica13 tion persistence, and methods to improve medication ad14 herence and persistence in Federal health programs. 

15 (b) ACTIVITIES INCLUDED.—The activities described 

16 in subsection (a) shall include development of annual sta17 tistics on recommended medications, the rate of medica18 tion adherence, the rate of primary nonadherence, and the 

19 rate of medication persistence for patients with chronic 

20 diseases such as cardiovascular disease, hypertension, dia21 betes, autoimmune diseases, chronic obstructive pul22 monary disease (COPD), and mental health conditions 

23 treated under the following health care programs: 

24 (1) MEDICARE.—The Medicare program under 

25 title XVIII of the Social Security Act. 

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1 (2) MEDICAID.—The Medicaid program under 

2 title XIX of such Act. 

3 (3) FEHBP.—The Federal Employees Health 

4 Benefit Program under chapter 89 of title 5, United 

5 States Code. 

6 (c) BIENNIAL REPORT ON MEDICATION ADHERENCE

7 AND MEDICATION PERSISTENCE.—Not later than 2 years 

8 after the date of enactment of this Act (and annually 

9 thereafter), the Secretary shall submit to Congress a re10 port on the statistics collected under subsection (a), to11 gether with recommendations for such legislation and ad12 ministrative action to address problems and improve medi13 cation adherence and medication persistence as the Sec14 retary determines appropriate. 

15 SEC. 5. TESTING MODELS FOR IMPROVING MEDICATION 

16 ADHERENCE. 

17 (a) IN GENERAL.—The Secretary shall test innova18 tive health care delivery models, as described in sub19 sections (b) and (c), to improve medication adherence and 

20 medication persistence, with the goal of improving health 

21 outcomes and decreasing health costs for chronic care con22 ditions. 

23 (b) MODELS TO TEST EFFICACY OF SYNCHRONI24 ZATION.— 

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1 (1) IN GENERAL.—The model described in this 

2 subsection shall test the efficacy of synchronization 

3 of prescription drug medications for applicable en4 rollees in improving medication adherence, deter5 mining cost avoidance, and improving outcomes for 

6 those enrollees. 

7 (2) PARTICIPATION.—An applicable enrollee 

8 who is eligible to participate in the model testing 

9 under this subsection shall participate in the model 

10 testing, unless the enrollee elects not to participate 

11 in the model. 

12 (3) MODELS TESTED.—The following models of 

13 synchronization shall be tested under this sub14 section: 

15 (A) MODEL 1.—Synchronization (synchro16 nization of prescription drug medications and 

17 medication reconciliation phone calls or elec18 tronic communication with enrollees prior to 

19 filling prescriptions). 

20 (B) MODEL 2.—Synchronization (as de21 scribed in subparagraph (A)) and compliance22 based packaging. 

23 (C) MODEL 3.—Synchronization (as de24 scribed in subparagraph (A)) and ongoing phar25 macist counseling that shall occur at the pamstockstill on DSK4VPTVN1PROD with BILLS

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1 tient’s request and include review of the appro2 priateness of the medication regimen and any 

3 barriers to medication adherence. 

4 (4) EVALUATION.—The Secretary shall evaluate 

5 the models in paragraph (3) by collecting and ana6 lyzing relevant plan and enrollee data, including at 

7 least the following: 

8 (A) Synchronization enrollment and drop9 out rates. 

10 (B) Primary medication nonadherence. 

11 (C) Medication adherence and persistence 

12 rates. 

13 (D) Demographic characteristics of appli14 cable enrollees. 

15 (E) Plan characteristics, such as plan ben16 efit design. 

17 (F) Impact of the models on applicable en18 rollees who are— 

19 (i) eligible for benefits under a State 

20 plan under title XIX of the Social Secu21 rity; or 

22 (ii) eligible for premium and cost23 sharing subsidies under section 1860D– 

24 14(a) of the Social Security Act (42 U.S.C. 

25 1395w–114(a)). 

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1 (G) Prescription drug claims data in com2 parison to other medical claims data for appli3 cable enrollees in order to examine the effect of 

4 synchronization and adherence on overall health 

5 spending, including health care costs avoided, 

6 and patient outcomes. 

7 (c) TESTING 90-DAY FILLS AT RETAIL PHARMACIES

8 FOR THE FIRST PRESCRIPTION.— 

9 (1) IN GENERAL.—The Secretary shall conduct 

10 a demonstration that compares the use of 90-day 

11 first fills of prescriptions at retail pharmacies or 

12 using mail-order for maintenance medications 

13 against 30-day first fills for applicable enrollees 

14 under part D of title XVIII of the Social Security 

15 Act, to determine whether there is an impact on 

16 medication persistence, cost avoidance, and improv17 ing outcomes for those enrollees in subsequent refill 

18 periods. 

19 (2) DRUGS TESTED.—The model under this 

20 subsection shall only pertain to first fills for mainte21 nance drugs treating chronic diseases such as car22 diovascular disease, hypertension, diabetes, auto23 immune diseases, chronic obstructive pulmonary dis24 ease (COPD), and mental health conditions. 

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1 (3) EVALUATION OF DEMONSTRATION BY

2 GAO.— 

3 (A) PROVISION OF DATA FOR EVALUA4 TION.—The Secretary shall make available to 

5 the Comptroller General of the United States 

6 relevant plan and enrollee data in order to en7 able an evaluation of the demonstration under 

8 this subsection under subparagraph (B). 

9 (B) EVALUATION.—Using data made avail10 able under subparagraph (A) and other relevant 

11 data, the Comptroller General of the United 

12 States shall evaluate the demonstration con13 ducted under this subsection. Such evaluation 

14 shall examine the effect of long-term fills and 

15 adherence on overall health spending, including 

16 health care costs avoided, and patient outcome, 

17 and shall examine at least the following in rela18 tion to part D enrollees using 90-day first fills 

19 in comparison with those enrollees using 30-day 

20 first fills: 

21 (i) Medication adherence and persist22 ence rates. 

23 (ii) Cost differentials in pharmacy 

24 costs. 

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1 (iii) Prescription drug claims data in 

2 comparison to other medical claims. 

3 (iv) Medication wastage (as defined in 

4 section 3). 

5 (C) REPORT.—The Comptroller General 

6 shall submit a report to the Secretary and Con7 gress on the evaluation conducted under this 

8 paragraph. 

Æ 

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